Health products policy and standards
Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.

Distribution

Any comprehensive system of quality assurance must be founded on a reliable system of controlling the quality, safety and efficacy of a finished product delivered to a market. It is imperative that all manufacturing operations are carried out in conformity with the accepted norms of GMP. 

The distribution channel and supply chain need to follow quality assurance as well in order that patients are getting quality medicines. WHO has issued international standards assisting Member States and those involved in the supply chain. 

Related documents

20 April 2022

TRS 1044 - Annex 8: Points to consider for setting the remaining shelf-life of medical products upon delivery

10 October 2021

TRS 1033 - Annex 9: Guidelines on the implementation of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce

17 February 2021

TRS 986 - Appendix 6: Interagency finished pharmaceutical product questionnaire

17 June 2020

TRS 1025 - Annex 7: Good storage and distribution practices for medical products

10 October 2019

TRS 1019 - Annex 5: Guidelines on import procedures for medical products

30 September 2018

TRS 1010 - Annex 5: WHO guidance on testing of “suspect” falsified medicines

10 October 2016

TRS 966 - Annex 7: Guidelines on the conduct of surveys of the quality of medicines

10 October 2016

TRS 966 - Annex 2: FIP–WHO technical guidelines: Points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products

10 October 2016

TRS 996 - Annex 6: WHO good trade and distribution practices for pharmaceutical starting materials

10 October 2015

TRS 992 - Annex 5: Technical supplements to Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products

10 October 2014

TRS 986 - Annex 4: Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection

30 September 2014

TRS 986 - Annex 3: WHO model quality assurance system for procurement agencies

10 October 2011

TRS 961 - Annex 9, Supplement 3: Estimating the capacity of storage facilities

10 October 2011

TRS 961 - Annex 8: Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services

10 October 2011

TRS 961 - Annex 9, Supplement 15: Temperature and humidity monitoring systems for transport operations

10 October 2011

TRS 961 - Annex 9, Supplement 16: Environmental management of refrigeration equipment

10 October 2011

TRS 961 - Annex 9, Supplement 13: Qualification of shipping containers

10 October 2011

TRS 961 - Annex 9, Supplement 2: Design and procurement of storage facilities

10 October 2011

TRS 961 - Annex 9, Supplement 8: Temperature mapping of storage areas

10 October 2011

TRS 961 - Annex 9, Supplement 12: Temperature-controlled transport operations by road and by air

10 October 2011

TRS 961 - Annex 9, Supplement 9: Maintenance of refrigeration equipment

10 October 2011

TRS 961 - Annex 9, Supplement 7: Qualification of temperature-controlled storage areas

10 October 2011

TRS 961 - Annex 9: Introduction to the Technical Supplements

10 October 2011

TRS 961 - Annex 9, Supplement 6: Temperature and humidity monitoring systems for fixed storage areas

10 October 2011

TRS 961 - Annex 9, Supplement 5: Maintenance of storage facilities

10 October 2011

TRS 961 - Annex 9, Supplement 14: Transport route profiling qualification

10 October 2011

TRS 961 - Annex 9, Supplement 1: Selecting sites for storage facilities

10 October 2011

TRS 961 - Annex 9, Supplement 11: Qualification of refrigerated road vehicles

10 October 2011

TRS 961 - Annex 9, Supplement 10: Checking the accuracy of temperature control and monitoring devices

10 October 2011

TRS 961 - Annex 9, Supplement 4: Building security and fire protection

2 August 2011

TRS 961 - Annex 9: Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products

10 October 2005

TRS 929 - Annex 4: WHO guidelines for sampling of pharmaceutical products and related materials

10 October 2003

TRS 917 - Annex 3: WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation